On November 17, local time, the U.S. Food and Drug Administration (FDA) approved Provention Bio 's immunotherapy Tzield (teplizumab), which is indicated to delay the onset of type 1 diabetes (T1D).
Teplizumab, an anti-CD3 monoclonal antibody, is the first approved therapy shown to delay the progression to stage 3 T1D for some people at high risk of developing the condition. The therapy is approved to treat adults and children 8 years and older who live with stage 2 T1D.
Teplizumab is administered by intravenous infusion once daily for 14 consecutive days.
“The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease,” said Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.
About Type 1 Diabetes (T1D)
T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death if left untreated.
People with a type 1 diabetes diagnosis have increased glucose that requires insulin shots (or wearing an insulin pump) to survive and must check their blood sugar levels regularly throughout the day.
Globally, it impacts nearly 9 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D.
About Tzield (teplizumab)
Teplizumab binds to certain immune system cells and delays the progression of T1D. The therapy may deactivate the immune cells that attack insulin-producing beta cells, while increasing the proportion of cells that help moderate the immune response, essentially stabilizing beta cell function.
Autoantibodies are antibodies made by your immune system that attack your own tissue and are often associated with autoimmune reactions. T1D-related autoantibodies can show up in blood tests months or years before the onset of the physical symptoms that typically lead to a diagnosis.
Clinical trials of teplizumab focused on participants who were already experiencing a decline in c-peptide levels, meaning that insulin production and beta cell function were already being impacted.
The median time from joining the study to the onset of stage 3 T1D was 50 months for the group that received teplizumab, versus 25 months for the group that did not receive the therapy.
Provention Bio 's Type 1 Diabetes Drug Teplizumab is FDA Approved
More time with preserved hormone function and stable blood sugar levels means less strain on the body caused by blood sugar fluctuations. Delaying the onset of T1D also means less time spent having to manage the condition and mitigating its risks and complications.
“This is a historic occasion for the T1D community and a paradigm-shifting breakthrough for individuals aged 8 years and older with Stage 2 T1D who now have a therapy approved by the FDA to delay the onset of Stage 3 disease,” Provention Bio co-founder and CEO Ashleigh Palmer said.
There are other long-term benefits to slowing the loss of beta cell function. By actively monitoring autoantibody levels and other markers of T1D in individuals who receive this preventative treatment, it’s possible to minimize the risk of–or even prevent—diabetic ketoacidosis (DKA). DKA is a life-threatening complication of diabetes and persistently high blood sugar that often leads to hospitalization.
The FDA granted Breakthrough Therapy Designation to teplizumab in 2019 after it became the first drug ever to demonstrate the delay of T1D onset successfully.
Hot Article：
